Recall Z-1683-2023 ยท QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Qiagen Sciences LLC
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
| Date | Jun 2, 2023 (initiated Apr 28, 2023) |
| Status | Open, Classified |
| Reason | Faulty cartridges in the lot could result in false test results. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification letter dated April 2023 was sent to customers. Actions to be taken by customer/user Please check if you have remaining stock of LOT 175011350. Please DO NOT use it. Dispose of it immediately in accordance to your national and local safety and environmental regulations. Please contact QIAGEN Technical Services for a free-of-charge replacement. If you already used cartridges from this LOT, please identify the results obtained with cartridges from the affected SN. For results obtained with an affected SN, review the results as follows: o Review |
| Quantity | 347 kits |
| Distribution | US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.